NCT02165228

Brief Summary

The long-term goal of the proposed research is to identify and develop effective interventions to decrease persistent, low-level inflammation and risk of CVD. Stress is a substantial contributor to inflammation, and interactions among stress, inflammation, body mass index, and health behaviors have been measured. Mindfulness-based stress reduction (MBSR) is effective for stress reduction, has been shown to be effective for inflammation reduction in individuals with disease, and is a sustainable practice for individuals across the health spectrum. Diet strategies are an effective means of reducing inflammation for some individuals, but may not be successful for many people, as evidenced by the steady rise in obesity rates. The specific aims of this study are to 1) test the effectiveness of MBSR compared to an established intervention of a nutrition enhancement (NE) intervention for the reduction of inflammation, and 2) test the effectiveness of MBSR compared to a non-intervention control conditions (CON) for the reduction of inflammation. Men and women 25-45 years of age will be randomly assigned to participate in MBSR (n=60) or DIET (n=60) or CON (n=60) interventions for 16 weeks. Serum CRP concentrations, additional inflammatory cytokines (tumor necrosis factor-a, interleukin-6), cortisol diurnal profiles, anthropometrics, dietary intake, and all components of the metabolic syndrome will be measured pre- and post-intervention to elucidate underlying mechanisms and to determine whether health benefits beyond inflammation reduction occur.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

2.2 years

First QC Date

June 13, 2014

Last Update Submit

June 13, 2014

Conditions

AtherosclerosisDiabetes

Outcome Measures

Primary Outcomes (2)

  • Inflammation Biomarkers

    C-reactive protein (CRP), tumor necrosis factor-alpha, interleukin-6

    16 weeks

  • Metabolic Syndrome Extent

    Blood pressure, waist circumference, fasting glucose, fasting HDL, fasting triglycerides, number of components

    16 weeks

Secondary Outcomes (8)

  • BMI

    16 weeks

  • Waist to hip ratio

    16 weeks

  • Cholesterol

    16 weeks

  • Insulin Resistance

    16 weeks

  • Stress hormone levels

    16 weeks

  • +3 more secondary outcomes

Study Arms (3)

Mindfulness-based stress reduction

EXPERIMENTAL

Stress reduction class and behavioral intervention

Behavioral: Mindfulness-based stress reduction

Nutrition Enhancement

ACTIVE COMPARATOR

Nutrition education class and behavioral intervention

Behavioral: Nutrition Enhancement

Control

NO INTERVENTION

No class or behavioral intervention

Interventions

Mindfulness-based stress reductionBEHAVIORAL

Stress reduction class and behavioral intervention

Mindfulness-based stress reduction
Nutrition EnhancementBEHAVIORAL

Nutrition education class and behavioral intervention

Nutrition Enhancement

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Elevated waist circumference or BMI

You may not qualify if:

  • Participation in calorie restricted diet in previous 30 d
  • Participation in stress reduction program in previous 30 d
  • Take blood pressure, lipid lowering or anti-inflammatory medications
  • Hypertension
  • Diabetes
  • Heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

Location

MeSH Terms

Conditions

AtherosclerosisDiabetes Mellitus

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mary P Miles, PhD

    Montana State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 17, 2014

Study Start

January 1, 2010

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

US(1)